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On the Edges: The Ethics of Human Studies with Psychedelic Substances

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Ethics and Clinical Neuroinnovation

Abstract

Classical psychedelics or hallucinogens, such as mescaline, psilocybin, dimethyltryptamine, and salvia, have been used in religious, shamanic, and spiritual ceremonies for millennia. The “psychedelic” or “mind-manifesting” effects of these substances have generated great scientific curiosity, with a large number of clinical studies conducted in the U.S. in the 1950s and 1960s. Early research suggested clinical benefits of psychedelics for many disorders, including alcohol use disorders and anxiety and depressive symptoms in life-threatening conditions. However, following the escalation of its recreational use, careless experimentation, and lack of consistent evidence of clinical benefits, psychedelic substances were classified as Schedule I substances by the Controlled Substance Act of 1970, denoting high potential for abuse, no accepted medical use, and lack of accepted safety for use under medical supervision, which, ultimately, severely limited research with these substances. After their criminalization in 1970, there was a period of dormancy in clinical research on psychedelics. However, continued interest in their unique psychoactive effects along with increased need for novel pharmacological agents in psychiatry has led to a renewed interest in the therapeutic potential of psychedelics over the past two decades. Research on these substances has proven to be particularly challenging. From methodological difficulties to regulatory constraints, this chapter provides an overview of the ethical aspects of human research on psychedelics.

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Further Reading

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da Costa, S.C., Sofuoglu, M. (2023). On the Edges: The Ethics of Human Studies with Psychedelic Substances. In: Roberts, L.W. (eds) Ethics and Clinical Neuroinnovation. Springer, Cham. https://doi.org/10.1007/978-3-031-14339-7_9

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